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Mallinckrodt States its Position on Legacy Acthar® Gel Legal Matter

- Original action filed in 2012, prior to Mallinckrodt's ownership of Acthar Gel
- Company strongly disagrees with substance of complaints and sensational characterization of allegations

 

April 30, 2019

Recently a  legacy legal matter stemming from allegations filed against the prior owner of  Acthar® Gel became public, and recent news stories have conveyed  those allegations. The company believes it is important to state its position  on this matter.

The U.S.  Department of Justice (DOJ) elected to join an existing civil False Claims Act  case against the company, which has been unsealed by a court in the Eastern District  of Pennsylvania. The original action was filed in 2012, prior to Mallinckrodt's  ownership of Acthar Gel, and consists of two complaints filed by former  Questcor employees. Questcor was the previous owner of Acthar Gel. The  allegations pertain principally to legacy Questcor conduct.

Importantly, Mallinckrodt  strongly disagrees with the substance of the complaints and the sensational  characterization of the allegations.

Mallinckrodt  has cooperated fully with the DOJ in its review of this historical conduct,  voluntarily providing documents and information to the government.  While we are disappointed the DOJ has elected  to proceed with the lawsuit, we have been in advanced settlement talks with the  government over the past several months.

The company believes these sales and  marketing claims are likely to be resolved in the near term through ongoing  negotiations, and further believes a resolution that is reasonable and manageable  for all parties is achievable.

As the lawsuit  principally concerns allegations of legacy conduct prior to Mallinckrodt's  acquisition of Acthar Gel, the company does not envision any impact to how  Mallinckrodt conducts business today.

ABOUT MALLINCKRODT
Mallinckrodt is a  global business consisting of multiple wholly owned subsidiaries that develop,  manufacture, market and distribute specialty pharmaceutical products and  therapies. The company's Specialty Brands reportable segment's areas of focus  include autoimmune and rare diseases in specialty areas like neurology,  rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and  neonatal respiratory critical care therapies; and analgesics. Its Specialty  Generics and Amitiza® reportable segment includes specialty generic drugs,  active pharmaceutical ingredients and AMITIZA (lubiprostone). To learn more  about Mallinckrodt, visit www.mallinckrodt.com.

Mallinckrodt uses  its website as a channel of distribution of important company information, such  as press releases, investor presentations and other financial information. It  also uses its website to expedite public access to time-critical information  regarding the company in advance of or in lieu of distributing a press release  or a filing with the U.S. Securities and Exchange Commission (SEC)  disclosing the same information. Therefore, investors should look to the  Investor Relations page of the website for important and time-critical information.  Visitors to the website can also register to receive automatic e-mail and other  notifications alerting them when new information is made available on the  Investor Relations page of the website.
 
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This  release includes forward-looking statements concerning Acthar Gel and related  legal matters. The statements are based on assumptions about many important  factors which could cause actual results to differ materially from those in the  forward-looking statements, and such factors are identified and described in  more detail in the "Risk Factors" section of Mallinckrodt's most  recent Annual Report on Form 10-K and other filings with the SEC, all of  which are available on its website. The forward-looking statements made herein  speak only as of the date hereof and Mallinckrodt does not assume any  obligation to update or revise any forward-looking statement, whether as a  result of new information, future events and developments or otherwise, except  as required by law.

CONTACTS
Media
Daniel Yunger
Kekst CNC
212-521-4879
mallinckrodt@kekstcnc.com
 
Investor Relations
Daniel J. Speciale, CPA
Vice President, Investor Relations and IRO
314-654-3638
daniel.speciale@mnk.com
 
 
Mallinckrodt, the "M" brand mark and  the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company.  Other brands are trademarks of a Mallinckrodt company or their respective  owners. © 2019 Mallinckrodt. 4/19

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